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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Spider Cervical Plating System - M697N600015031

NON-RATCHETING T-HANDLE MINI AO DRIVER
Xtant Medical Holdings, Inc.
N60001503
In Commercial Distribution

  • M697N600015030 ()
  • M697N600015031 ()


  • Spinal fixation plate, non-bioabsorbable

Spider Cervical Plating System - M697N600015021

RATCHETING MINI AO DRIVER
Xtant Medical Holdings, Inc.
N60001502
In Commercial Distribution

  • M697N600015020 ()
  • M697N600015021 ()


  • Spinal fixation plate, non-bioabsorbable

Spider Cervical Plating System - M697N600009271

AO Hex Driver
Xtant Medical Holdings, Inc.
N60000927
In Commercial Distribution

  • M697N600009270 ()
  • M697N600009271 ()


  • Spinal fixation plate, non-bioabsorbable

Irix-A Lumbar Integrated Fusion System - M697C08000801

IRIX A UNIVERSAL JOINT GUIDED HEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0080
In Commercial Distribution

  • M697C08000800 ()
  • M697C08000801 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C0800072151

UNIVERSAL JOINT GUIDED HEX DRIVER, ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0072-15
In Commercial Distribution

  • M697C0800072150 ()
  • M697C0800072151 ()


  • Polymeric spinal interbody fusion cage

Silex Sacroiliac Joint Fusion System - M697C07902641

SPECIAL 7mm ADJUSTMENT IMPLANT DRIVER, CANNULATED
Xtant Medical Holdings, Inc.
C079-0264
In Commercial Distribution

  • M697C07902640 ()
  • M697C07902641 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Silex Sacroiliac Joint Fusion System - M697C07900261

CUSTOM IMPACTION DRIVER
Xtant Medical Holdings, Inc.
C079-0026
In Commercial Distribution

  • M697C07900260 ()
  • M697C07900261 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

Silex Sacroiliac Joint Fusion System - M697C07900111

SPECIALTY 12.5 mm IMPLANT DRIVER
Xtant Medical Holdings, Inc.
C079-0011
In Commercial Distribution

  • M697C07900110 ()
  • M697C07900111 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Aranax Anterior Cervical Plating System - M697T08612001

SCREW DRIVER
Xtant Medical Holdings, Inc.
T086-1200
In Commercial Distribution

  • M697T08612000 ()
  • M697T08612001 ()


  • Spinal fixation plate, non-bioabsorbable

Xspan Laminoplasty Fixation System - M697T085001011

SHAFT, HEX SCREW DRIVER
Xtant Medical Holdings, Inc.
T085-0010-1
In Commercial Distribution

  • M697T085001010 ()
  • M697T085001011 ()


  • Spinal fixation plate, non-bioabsorbable
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